SGLT2-Inhibitors for Sleep Apnea in Heart Failure

Sponsor

Columbia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04640493

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Heart Failure is a disease involving many different aspects of the human body, including changes in metabolism, the way the body produces and uses energy. Research shows that patients with heart failure often have a sleep disorder called sleep disordered breathing (SDB). It has been shown that SDB is associated with poor outcomes in heart failure patients, but the exact reason is unknown. It is likely that SDB leads to changes in metabolism and hormone status in the body, which is especially dangerous for heart failure patients. There is currently no treatment for SDB in heart failure patients. Recently, with Sodium glucose co-transporter 2 (SGLT2)-Inhibitors a new drug class has been approved for the treatment of advanced heart failure. This drug has effects on the metabolism in heart failure patients, among several other effects. This research project has the aim to investigate if SGLT2 inhibitors can help in the treatment of SDB, as many mechanisms of the drug overlap with the mechanisms how SDB develops. The drug has been approved by the FDA for the treatment of heart failure. The investigators want to study the effect of the drug on SDB by using a home sleep test called Watchpat, which has been approved to diagnose SDB.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure Sleep Disordered Breathing	Drug: Dapagliflozin Device: WatchPat	Phase 2

Detailed Description

To explore whether SGLT2-Inhibition has a beneficial effect on Sleep Disordered Breathing (SDB) in advanced heart failure patients. This project proposes to carry out research that addresses the established, but in clinical practice under-recognized association between Sleep Disordered Breathing (SDB) and a worse prognosis in patients with heart failure (HF). SDB is highly prevalent in the HF population. Multiple studies have shown that HF accompanied by SDB is associated with an increased mortality compared to the absence of SDB. Two major types of SDB are prevalent in HF: Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA). Mechanistically, it has been proposed that SDB impacts the neurohumoral axis and systemic metabolism and therefore has particularly detrimental effects on the HF patient population. Therapeutic options for the treatment of SDB are limited. Heart Failure is a multisystemic disease leading to maladaptive cardiac and systemic metabolic changes. Recently, with SGLT2-Inhibitors a new drug class has been approved for the treatment of advanced heart failure. This is the first drug class in the HF drug armamentarium targeting cardiometabolic mechanisms. This study seeks to improve the health of individuals with heart failure by exploring whether SGLT2-Inhibition has a beneficial effect on SDB (OSA and CSA) in advanced heart failure patients and therefore may be a novel therapeutic option for the treatment of SDB in advanced HF. The specific aim of this project is to assess the effect of therapy with a SGLT2-I on SDB in ambulatory advanced HF patients by using the WatchPAT-derived apnea-hypopnea index as well as subjective measures of sleep quality using the Berlin Questionnaire and Epworth Sleepiness Scale.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Study design is prospective, non-randomized, interventional (non-experimental) pre-post studyStudy design is prospective, non-randomized, interventional (non-experimental) pre-post study

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

The Effect of Sodium Glucose Co-transporter 2 (SGLT2)-Inhibitors on Sleep Disordered Breathing in Heart Failure Patients

Anticipated Study Start Date :

Apr 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SGLT2-SDB Patients with newly diagnosed SDB will be given dapagliflozin (standard dosage, 10mg)	Drug: Dapagliflozin If patients have been diagnosed with SDB using the WatchPat device, they will start dapagliflozin. Repeat WatchPat SDB assessment will be performed after 3 and 6 months of continuous dapagliflozin therapy. Other Names: FARXIGA Device: WatchPat HF patients undergo SDB testing with the WatchPat device.

Arm

Intervention/Treatment

Experimental: SGLT2-SDB

Patients with newly diagnosed SDB will be given dapagliflozin (standard dosage, 10mg)

Drug: Dapagliflozin

If patients have been diagnosed with SDB using the WatchPat device, they will start dapagliflozin. Repeat WatchPat SDB assessment will be performed after 3 and 6 months of continuous dapagliflozin therapy.

Other Names:

FARXIGA

Device: WatchPat

HF patients undergo SDB testing with the WatchPat device.

Outcome Measures

Primary Outcome Measures

Change in Apnea-Hypopnea Index [6 months]
Change in the apnea-hypopnea index as measured by the WatchPAT device.
Change Berlin Questionnaire Categorization [6 months]
The Berlin Questionnaire for sleep apnea consists of 3 categories related to the risk of having sleep apnea. Participants are classified as "High Risk" or "Low Risk" for sleep apnea. High risk categorization is assigned when there are 2 or more categories where the score is positive ("positive" defined as a score of 2 or more points). Low risk categorization is assigned when there is 1 or no categories where the score is positive.
Change in Epworth Sleepiness Scale [6 months]
The Epworth Sleepiness Scale is an 8-item scale measuring sleepiness in various situations. Each situation is scored as 0=no chance of dozing to 3= high chance of dosing. Scores range from 0-24, with a higher score indicating a higher level of sleepiness.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consent-able adults
Diagnosis of heart failure
Diagnosis of SDB
No contraindication for taking dapagliflozin

Exclusion Criteria:

Patients without heart failure
Patients without SDB
Contraindication for taking dapagliflozin (severe renal impairment, hemodialysis, or history of severe hypoglycemic episodes)